1. Field of the Inventive Subject Matter
The inventive subject matter relates to novel devices and methods for promoting or enhancing male erectile function, and for treating erectile dysfunction.
2. Background
More than 100 years ago, G. R. Phillips, M.D. wrote the following in the St. Louis Medical Era, 1895-1896: “With rare exceptions, it is the evident intent of nature that every adult male be accorded the pleasure, satisfaction and the power of performing the sexual act. When a condition exists that strips one of this right, be the condition a real or a fancied ill, we have resulting impotence. To acquire an erection is essential, to maintain the same for a time sufficient for the completion of the sexual act is equally so, that one may be potent.” All fields of medical science advanced during the Victorian Age, and the study of the male penis became scientific. Early urologists laid down rules in an exact science for performing observations and testing the soundness of the their conclusions. Their conclusions were that impotency does exist.
Now, more than 100 years later and with all the research done on this subject, millions of men around the world still suffer erectile dysfunction at some time in their lives.
Erectile dysfunction affects millions of men. It is estimated that the number of American men with erectile dysfunction ranges from 15 million to 30 million. Although for some men erectile function may not be the best or most important measure of sexual satisfaction, for many men erectile dysfunction creates mental stress that affects their interactions with family and associates. Many advances have occurred in both diagnosis and treatment of erectile dysfunction. However, its various aspects remain poorly understood by the general population and by most health care professionals. Lack of a simple definition, failure to delineate precisely the problem being assessed, and the absence of guidelines and parameters to determine assessment and treatment outcome and long-term results, have contributed to this state of affairs by producing misunderstanding, confusion, and ongoing concern.
Prior-art Treatments of erectile dysfunction. Erectile dysfunction can be treated, with variable degrees of success, by a variety of methods. Most physicians suggest that treatments proceed from least to most invasive. Cutting back on drugs with harmful side effects is considered first. For example, different drugs for high blood pressure work in different ways. Psychotherapy and behavior modifications in selected patients are considered next if indicated, followed by oral or locally injected drugs, vacuum devices, and surgically implanted devices. In rare cases, surgery involving veins or arteries may be considered.
Psychotherapy. Experts often treat psychologically based erectile dysfunction using techniques that decrease the anxiety associated with intercourse. The patient's partner can help with the techniques, which include gradual development of intimacy and stimulation. Such techniques also can help relieve anxiety when erectile dysfunction from physical causes is being treated.
Drug Therapy. Drugs for treating erectile dysfunction can be taken orally, injected directly into the penis, or inserted into the urethra at the tip of the penis. In March 1998, the Food and Drug Administration approved Viagra, the first pill to treat erectile dysfunction. Recently, the FDA granted approval for two additional oral medications, vardenafil hydrochloride (Levitra) in August 2003 and, most recently, Cialis (tadalafil) in November 2003.
Additional oral medicines are being tested for safety and effectiveness. Taken before sexual activity, Viagra, Levitra and Cialis work by enhancing the effects of nitric oxide, a chemical that relaxes smooth muscles in the penis during sexual stimulation and allows increased blood flow. While oral medicines improve the response to sexual stimulation they do have potential side effects and other limitations, such as delayed time of onset. Further, men who take nitrate-based drugs, such as nitroglycerin for heart problems, should not use any of these medications because the combination can produce a sudden drop in blood pressure. In addition, none of these medications should be taken with any of the drugs called alpha-blockers, which are used to treat prostate enlargement or high blood pressure.
Oral testosterone can reduce erectile dysfunction in some men with low levels of natural testosterone, but it is often ineffective and may produce liver damage. Patients also have claimed that other oral drugs—including yohimbine hydrochloride, dopamine and serotonin agonists, and trazodone—are effective, but the results of scientific studies to substantiate these claims have been inconsistent. Improvements observed following use of these drugs may be examples of the placebo effect.
Many men achieve stronger erections by injecting drugs into the penis, causing it to become engorged with blood. Drugs such as papaverine hydrochloride, phentolamine, and alprostadil widen blood vessels. However, along with the inconvenience of injections, such drugs may create unwanted side effects, including persistent erection and scarring.
A system for inserting a pellet of alprostadil into the urethra is also currently available. The system uses a prefilled applicator to deliver the pellet about an inch deep into the urethra. An erection will begin within 8 to 10 minutes and may last 30 to 60 minutes. The most common side effects are aching in the penis, testicles, and area between the penis and rectum; warmth or burning sensation in the urethra; redness from increased blood flow to the penis; and minor urethral bleeding or spotting.
Constriction and Vacuum/Constriction Devices. Mechanical vacuum/constriction devices produce erection by creating a partial vacuum around the penis, which draws blood into the penile corpora cavernosa, engorging and expanding the penis. The devices have three components: (a) a plastic cylinder, which covers the penis; (b) a pump, which draws air out of the cylinder; and (c) an elastic ring, which, when fitted over the base of the penis, traps the blood and sustains the erection after the cylinder is removed and during sexual activity. One variation of the vacuum/constriction device involves a semirigid rubber sheath that is placed on the penis and remains there after erection is attained and during intercourse.
Vacuum/constriction devices are at times effective at generating and maintaining erections in some patients with erectile dysfunction. However, as with intracavernosal injection therapy, there is a significant rate of patient dropout with these devices: the devices are difficult for many patients to use, and this is especially so in those with impaired manual dexterity. Also, vacuum/constriction devices may impair ejaculation, which then produces patient discomfort. Patients and their partners often are bothered by the lack of spontaneity in sexual relations that may occur with this procedure. The patient is at times also bothered by the general discomfort that can occur while using vacuum/constriction devices. Further complicating their use, partner involvement in training with vacuum/constriction devices is often important for successful outcome, especially in regard to establishing a mutually satisfying level of sexual activity.
Constriction devices are known in the art. Representative U.S. Patents to penile constriction devices include the following:
U.S. Pat. No. 5,295,946 issued Mar. 22, 1994 to Collins, discloses a device for affecting or enhancing erection of the penis, comprising an external inflatable cuff which encircles the shaft of the penis at its base and extends distally. The cuff is provided with a plurality of volume expandable annular spaces arranged parallel to one another. The spaces are filled with fluid under pressure from a squeeze bulb to affect a tourniquet action. The spaces are inflated sequentially in a proximal to distal direction.
U.S. Pat. No. 5,306,227 issued Apr. 26, 1994 to Osbon, et al., discloses an integral cincture band of elastic material which includes a pair of semi-ellipsoidal handles and an enlarged region to be aligned with the urethra of the user's male sex organ so as to relatively reduce the urethral constriction for improved seminal fluid discharge. Radially inwardly projecting regions of predetermined radius of curvature which is relatively large to the overall ring are provided in predetermined circumferential locations on each lateral side of the dorsal centerline. Relatively inelastic material, such as spherical elements of hardened plastic, may be included in the inwardly projecting regions to further enhance specific circumferentially located blood flow restriction pressures.
U.S. Pat. No. 5,327,910 issued Jul. 12, 1994 to Flynn, discloses a therapeutic device for the treatment of male sexual dysfunction, which has first and second substantially rigid portions interconnected by malleable or deformable portions. The device is fitted to the base of the male penis and by selective deformation of the device, the first portion constricts blood flow through the penile veins to enable the user to achieve a penile erection; the second portion constricts the urethra to prevent premature ejaculation; and the malleable or deformable portions constrict blood flow through the penile arteries to overcome Priapism. The device has a core, e.g. of copper wire, within a deformable resilient sheath, with grooves or slots which allow blood flow through the blood vessels under the skin of the penis when in use.
U.S. Pat. Nos. 5,421,324 and 5,526,803 issued Jun. 6, 1995 and Jun. 18, 1996, respectively, to Kelly, disclose a male truss for assisting in producing and maintaining an erection. A linear rigid member is mounted upon a loop capable of drawing the member into biasing contact against the dorsal side of the penis to restrict the flow of blood moving through the dorsal vein.
U.S. Pat. No. 5,439,007 issued Aug. 8, 1995 to Fischer, discloses a suspensory for improving the erection of the human male penis by means of deliberately choking the backflow of the venous blood, including a rigid, generally rectangular ring composed of two crossbars and two sidebars, which, in use, surrounds the penis as well as the scrotum, and which carries one rounded bulge at the center of its upper crossbar that presses on the topside of the penis near the abdomen, and one bulge on or adjacent its lower bar that presses on the root of the penis at the backside of the scrotum. These two bulges are shaped and placed such as to choke all three main veins, the vena dorsalis superficialis and the vena dorsalis profunda penis at the topside of the penis, and the venae profundae penis at the underside of the penis behind the scrotum, such that the arteries and nerve cords of the penis that run parallel to those choked veins are crowded sideways by said bulges into the empty corners of the rectangular ring so that arteries and nerve cords remain essentially unchoked. The lower bulge may be provided on a rearward extension rod which carries a rectal cone.
U.S. Pat. No. 5,695,444 issued Dec. 9, 1997 to Chaney, discloses an elastic ring for assisting a male to obtain and maintain an erection, having two prongs circumferentially spaced apart and extending from the inside diameter of the ring inwardly of the ring opening and has a protuberance formed on the inside of ring substantially diametrically opposite of the prongs. The device encircles the penis and scrotum so as to apply a compressive force rearwardly of the root of the penis so that the external conspicuous part of the penis and the more concealed root part can become rigidified or erect and involved in the sexual act.
U.S. Pat. No. 5,997,469 issued Dec. 7, 1999 to Northcutt, discloses a sexual aid device that encircles the base of the penis. The device may be constructed as a single ring, or as a set of rings that can be used together in various conformations. The device includes a size adjustment means that allows the user to vary the size of the central through hole so that a user of the device is always ensured of a proper fit. The device may also include an extension means to directly stimulate the female's clitoral region. Alternatively, the device may be formed with an oval shape as opposed to a round shape to achieve the objective of direct stimulation of the clitoris.
U.S. Pat. No. 6,319,194 issued Nov. 20, 2001 to Wulf, discloses a penis erection stabilizer adapted for mounting on the base of a male penis. The stabilizer includes an outer ring, a concentric smaller inner ring and a latex sheath. The latex sheath connects the two rings. The outer ring and smaller inner ring are also made of latex. One end of the sheath is attached to an inner circumference of the outer ring. An opposite end of the sheath is attached to an inner circumference of the inner ring. In operation, the outer and inner ring are stretched over the head of the penis and along the length of the penis. The smaller inner ring is then placed next to the base of the penis and next to the torso with the outer ring disposed around the inner ring. The inner ring with added pressure from the outer ring provide a necessary pressure to contain the blood supply in the penis, thus helping insure a natural erection. Also, the inner ring can be unrolled from a portion of the sheath for placing the inner ring next to the upper ring.
These prior art patents do not describe the novel and improved inventive subject matter claimed herein.
Surgery. Surgery for treating erectile dysfunction usually has one of three goals:                1. to reconstruct arteries to increase flow of blood to the penis;        2. to block off veins that allow blood to leak from the penile tissues; or        3. to implant a penile prosthesis device that can allow the penis to become erect.        
Surgery to repair arteries can reduce erectile dysfunction caused by obstructions that block the flow of blood. The best candidates for such surgery are young men with discrete blockage of an artery because of an injury to the crotch or fracture of the pelvis. However, the procedure is not widely used, as it is almost never successful in older men with widespread arterial blockage.
Surgery to veins that allow blood to leave the penis usually involves an opposite procedure—intentional blockage. In theory, blocking off veins can reduce the leakage of blood that diminishes the rigidity of the penis during erection. However, experts have raised questions about the long-term effectiveness of ligation, and it is rarely used.
Implanted devices, known as prostheses, can restore the ability to achieve erection in many men with erectile dysfunction. Various forms of penile prostheses are available for patients who fail with, or refuse, other forms of therapy; essentially, there are two basic designs: rigid or semi-rigid, and inflatable.
Rigid, malleable, and semirigid penile prostheses consist of specially constructed rods, generally plastic or silicone rubber, which are placed inside the corpora cavernosa of the penis. Such devices are implanted via an incision made on the underside the penis, and one rod is inserted in each corpora cavernosa. The procedure is an ambulatory, out patient procedure. It is particularly useful for the elderly and those with reduced strength of hands because its use requires no special manipulation. The user manually adjusts the position of the penis and, therefore, the rods. Adjustment does not affect the width or length of the penis.
Inflatable implants consist of paired cylinders, which are surgically inserted inside the penis and can be expanded using pressurized fluid. Tubes connect the cylinders to a fluid reservoir and a pump, which are also surgically implanted. The patient inflates the cylinders by pressing on the small pump, located under the skin in the scrotum. Inflatable implants can expand the length and width of the penis somewhat. They also leave the penis in a more natural state when not inflated. With an inflatable implant, erection is produced by squeezing a small pump implanted in a scrotum. The pump produces fluid to flow from a reservoir residing in the lower pelvis to cylinders residing in the penis. The cylinders expand to create the erection.
The effectiveness, complications, and acceptability vary among the types of prostheses, with the main problems being mechanical failure, infection, and erosions. Silicone particle shedding has been reported, including migration to regional lymph nodes. There is also a risk of the need for subsequent operation(s) with all mechanical devices. Although the inflatable prostheses may yield a more physiologically natural appearance, they have had a higher rate of failure requiring reoperation. Men with diabetes mellitus, spinal cord injuries, or urinary tract infections have an increased risk of prosthesis-associated infection. This form of treatment is considered to be inappropriate in patients with severe penile corporal fibrosis, or severe medical illness. Circumcision may also be required for patients with phimosis and balanitis.
Technologies in Development. Advances in implants, suppositories, injectable medications, and vacuum devices have expanded the options for men seeking treatment for erectile dysfunction. These advances have also helped increase the number of men seeking treatment. Gene therapy for erectile dysfunction is now being tested in several centers and may offer a long-lasting therapeutic approach for select causes of erectile dysfunction involving genetic deficiencies.
The National Institute of Diabetes and Digestive and Kidney Diseases (“NIDDK”) sponsors programs aimed at understanding the causes of erectile dysfunction and finding treatments to reverse its effects. NIDDK's Division of Kidney, Urologic, and Hematologic Diseases supported the researchers who developed Viagra and continue to support basic research into the mechanisms of erection and the diseases that impair normal function at the cellular and molecular levels, including diabetes and high blood pressure.
Despite increasing emphasis on eliminating the stigma that some perceive as surrounding erectile dysfunction, and increasing emphasis on actively treating erectile dysfunction using the methods and devices described above, there remains a significant need for novel and improved devices and methods for promoting or enhancing male erectile function, and for treating erectile dysfunction. Most particularly, there is a great need for comparatively simple, inexpensive, and non-invasive devices and methods of first resort which can be used by persons suffering from erectile dysfunction.
The inventive subject matter satisfies this need by providing novel devices and methods for promoting or enhancing male erectile function, and for treating erectile dysfunction. Advantages of the inventive subject matter over the prior art include:
Safety. In general, the FDA recommends that devices which constrict the user's penis be worn for no longer than 45 minutes at a time. The inventive devices can be safely worn for at least the maximum time recommended by the FDA.
Effectiveness. As discussed in detail herein, the inventive devices are at least as effective as any constrictive device.
Convenience. The inventive devices are simple to use, washable, and are expected to be easily replaceable if damaged.
Comfort. The inventive devices are as comfortable to use as “novelty” penis rings while providing a therapeutic benefit, and are significantly more comfortable than prior art constrictive devices having wire, metal, and hard plastic parts.
Partner Acceptance. The inventive devices are unobtrusive in use and may bring additional pleasure to the user's sexual partner. Further, the inventive devices are simple and quick to apply to the user's penis, promoting spontaneity in initiating sexual activity and avoiding distraction during sexual activity.
It is expected that the inventive devices and methods will be most beneficial to patients having reversible causes of erectile dysfunction, such as:                1. Patients on medications for high blood pressure;        2. Patients on medicines for depression;        3. Patients who have endocrine problems, such thyroid or pituitary problems;        4. Patients who have partner conflict;        5. Patients who smoke cigarettes;        6. Patients who use recreational drugs such as alcohol, methamphetamine, cocaine, and heroin;        7. Patients who have an anatomical abnormality of the penis; and        8. Patients with a correctable cause of vascular impotence.        
However, the inventive devices may be utilized by any man for promoting or enhancing erectile function, including specifically those men who have no perceived or diagnosed erectile dysfunction, yet wish to have firmer, longer-lasting erections more often or more consistently.